Skip to main content
OpenTrials
Completed

NCT Number: NCT01318798

Development and Validation of an Enhanced Prediction Score for Postoperative Acute Renal Failure After Liver Resection

Post-operative acute renal failure is a severe post-operative complication and is associated with high mortality. The enhanced prediction score, including pre-as well as intra-operative predictors accurately predicted ARF following hepatic surgery. This prediction score allows early identification of patients at high risk of ARF and may support decision-making for protective kidney treatment.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Zurich, Departmente of Visceral and Transplantation Surgery

Zurich, 8091, Switzerland

About this study

To enhance and validate an already pre-existing score accurately predicting post-operative acute renal failure (ARF) after hepatic surgery

We will enhance a pre-existing score predicting ARF based on pre-operative as well as intra-operative predictors.

Development process: we will identify the strongest predictors of ARF in a multivariable logistic regression model followed by a stepwise backward logistic regression analysis and bootstrapping.

Validation process: we will perform an internal validation by calibrating the prediction model as well as by k-fold cross validation (c statistics) and bootstrapping. Additionally, we will calculate the discrimination by the area under the curve (AUC).

Decision curve analysis: Furthermore we will perform a decision curve analysis to evaluate the clinical consequences of both prediction scores whether a patient with increased ARF risk would post-operative benefit of a treatment on the ICU.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • scheduled for liver surgery
  • benign as well as malignant diseases

Exclusion criteria

  • liver trauma
  • incomplete data sets
  • pre-operative chronic renal failure requiring hemodialysis

Treatment and study plan

Primary outcomes

  1. Development of an enhanced prediction score for ARF

    Time frame: within 48 hours post-operative

    Development of an enhanced but still simple and easy applicable score based on pre- and extended by intra-operative risk factors to predict postoperative ARF in patients scheduled for liver resection

Secondary outcomes

  1. Decision curve analysis

    Time frame: within 48 hours post-operative

    Describing a decision making model by performing a decision curve analysis for clinical consequences of the enhanced prediction score and comparing it with the pre-operative prediction score

  2. internal validation of the enhanced prediction score

    Time frame: within 48 hours post-operative

    internal Validation: discrimination, calibration, k-fold cross validation and bootstrapping

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Development and Validation of an Enhanced Prediction Score for Post-operative Acute Renal Failure Following Liver Resection

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 18, 2011
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.